UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029671 |
|---|---|
| Receipt number | R000033900 |
| Scientific Title | Phase 1-2 study on preventive effect of compression therapy using newly developed glove for oxaliplatin-induced peripheral neuropathy in colorectal cancer chemotherapy |
| Date of disclosure of the study information | 2017/11/01 |
| Last modified on | 2019/03/04 12:22:46 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Phase 1-2 study on preventive effect of compression therapy using newly developed glove for oxaliplatin-induced peripheral neuropathy in colorectal cancer chemotherapy
Acronym
Study on preventive effect using newly developed glove for oxaliplatin-induced peripheral neuropathy
Scientific Title
Phase 1-2 study on preventive effect of compression therapy using newly developed glove for oxaliplatin-induced peripheral neuropathy in colorectal cancer chemotherapy
Scientific Title:Acronym
Study on preventive effect using newly developed glove for oxaliplatin-induced peripheral neuropathy
Region
| Japan |
Condition
Condition
colorectal cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Examination of preventive effect using newly developed glove for oxaliplatin-induced peripheral neuropathy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety and effectiveness of new development glove
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
newly developed glove
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients planning treatment with oxaliplatin
2) Patients who are over 20 years of age at consent acquisition
3) No gender
4) After receiving sufficient explanation for the participation of this study, patients who gained written consent by the patient's free will with sufficient understanding
Key exclusion criteria
1) Patients with no peripheral neuropathy of Grade 1 or higher before starting the study
2) Patients who have not had a history of treatment with L-OHP in the past
3) Patients with disabilities or lesions difficult to wear gloves on the skin
4) Other Research Responsibilities (Sharing) Patients judged by doctors as inappropriate as subjects
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akiyoshi Kanazawa |
Organization
Shimane Prefectural Central Hospital
Division name
Department of Surgery
Zip code
Address
Himebara 4-1-1. Izumo, Shimane
TEL
0853-22-5111
kana@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akiyoshi Kanazawa |
Organization
Shimane Prefectural Central Hospital
Division name
Department of Surgery
Zip code
Address
Himebara 4-1-1. Izumo, Shimane
TEL
0853-30-6590
Homepage URL
kana@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Shimane Prefectural Central Hospital
Institute
Department
Personal name
Funding Source
Organization
Shimane Prefectural Central Hospital
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 10 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 02 | Month | 10 | Day |
Date trial data considered complete
| 2019 | Year | 02 | Month | 15 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 23 | Day |
Last modified on
| 2019 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033900
